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Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy children who undergo scoliosis surgery. The purpose of our study is to compare the effect of NPWT on infection rates when compared to standard gauze dressing. Participants will be randomized to the "NPWT" or "standard dressing" group. We will compare infection rates between the two groups. We hypothesize participants in the "NPWT" group will have a lower infection rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT | Experimental | subjects will undergo negative pressure wound therapy |
|
| Standard Gauze | Active Comparator | standard method of using gauze and dressing will be utilized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device |
| ||
| Standard Gauze Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Infection | Wounds will be classified as prolonged discharge if they have persistent sterile drainage on post-op day 5 or after, or as "infected," if cellulitis is found at suture line (erythema >1cm + tenderness + localized swelling + warmth). Wound assessment will be carried out by a clinical fellow on day 5 and subsequent days till discharge. Patients will also be assessed for other signs of infection such as Fever, Chills, and increase in pain or changes in appetite. Standard infection work-up will be utilized to rule in or rule out infection. | up to post op day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Time for wound closure | This will be measured intra-operatively in the operating room from the beginning of deep wound closure till complete skin closure either with standard treatment or by NPWT. Though this outcome measure may not appear to have much value as these surgeries are of a long duration, we considered it important from the surgeon's perspective. | intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Recruiting | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
| Cosmetic results | (Hollander wound evaluation scale): This is a validated cosmetic scoring system [8], which gives a score from 0 to 6. The score addresses six clinical variables: step off borders, contour irregularities, scar width, edge inversion, excessive inflammation, and overall cosmetic appearance. Each of these categories is graded on a 0- or 1-point scale where a score of 6 is considered optimal. At 12 weeks post-op follow-up, assessment of the scar will be carried out by an independent investigator who will be blinded to which treatment group the patient belongs to. | 12 weeks post op |
| Caregiver/parental satisfaction | This will analyzed on a visual analog scale (VAS) | 12 weeks post op |
| Wound dehiscence | Any gaping of the spinal wound > 5cm exposing subcutaneous tissue or deeper planes will be considered as indicative of wound dehiscence. This will be looked for at the 5th post- operative day during dressing change till 14 days post-op. | psot op day 5 to discharge |
| Foreign body reaction | Any evidence of foreign body reaction will be looked for at the two week mark and at 12 weeks post-op follow up. The presence of swelling under the wound over the suture or NPWT site in the absence of fever, significant redness and tenderness will be indicative of foreign body reaction. | 12 weeks post op |